A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Dose-Titration Study to Assess the Efficacy of Lercanidipine 10 mg and 20 mg Once Daily p. o. in Hypertensive Subjects (I or II WHO) With Elevated Body Weight.

UCB Pharma0 个研究点目标入组 180 人开始时间: 2004年5月1日最近更新: 2008年3月10日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: UCB Pharma
入组人数: 180
主要终点: change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment

A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension

•Body Mass Index (BMI): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included);
•Essential hypertension I or II WHO:
•140 mmHg ≤ BPs ≤ 179 mmHg and BPd ≤ 109 mmHg at the end of the placebo run-in phase;

•Secondary hypertension;
•Diabetes mellitus type 1, insulin dependent diabetes mellitus type 2, fasting blood glucose ≥ 160 mg/dl;
•Subjects keeping to a hypocaloric diet (except special diet for diabetics) to reduce body weight;
•History or presence of angioneurotic oedema;
•Subjects developing a hypertensive crisis during wash-out or placebo run-in period;

change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment

Blood pressure, response rate, normalization rate, pulse rate, lipid profile, safety and tolerability. Measures after 4, 8, 12 weeks.

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